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Pancreatic CancerPhase 2NCT00553813

A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer

A Phase 2 study testing TPI 287 in people with Pancreatic Cancer, run by Cortice Biosciences, Inc. at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of the study is to assess the activity of TPI 287 as single agent therapy for patients with advanced, unresectable pancreatic cancer after failure of gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month survival rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
TPI 287
Type of treatment
Injection or infusion
How many people
23 participants
Where
4 sitesin 2 countries
Study dates
Oct 2007to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histological or cytological confirmation of ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
  • Patients must have metastatic disease precluding curative surgery
  • Patients must have received only one prior systemic anticancer treatment for their advanced disease, which must have included a gemcitabine-based therapeutic regimen for advanced disease
  • Patients may have received prior adjuvant therapy for their disease
  • Patients must have a Karnofsky performance status ≥ 70 (Appendix I)
  • Patients must be ≥ 18 years of age
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  • Women of childbearing potential (WOCBP):
  • Must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study
  • Must have a negative serum or urine pregnancy test
  • Patients must have adequate organ function:
  • Bone marrow reserve as evidenced by: Absolute neutrophil count ≥1,500/uL, Platelet count ≥ 100,000/uL
  • Renal function as evidenced by serum creatinine ≥ 2.0 mg/uL
  • Hepatic function as evidenced by: Serum total bilirubin < 2.0 mg/uL, SGOT/SGPT < 3X ULN for the reference lab (< 5X ULN for patients with known hepatic metastases)
  • Patient must have recovered from prior surgery, radiotherapy or other antineoplastic therapy
  • Patients or their legal representative must be able to read, understand, and sign the informed consent to participate in the trial

Who cannot join

  • Patients with islet cell tumors, lymphoma, or sarcoma of the pancreas
  • Patients with more than one prior treatment for metastatic pancreatic carcinoma
  • Patients with current peripheral neuropathy > Grade 1
  • Patients receiving any concurrent chemotherapy, radiotherapy, hormonal therapy or immunotherapy
  • Patients with serious infection or a life-threatening illness (unrelated to tumor) that is > Grade 2 NCI CTCAE V 3.0), or active, serious infections requiring parental antibiotic therapy within 4 weeks prior to screening
  • History of cardiac disease or events according to the New York Health Association (NYHA) assessments. Clinically evident congestive heart failure as defined by NYHA Class 3 or 4 CHF or cardiac arrhythmia, including atrial fibrillation, if not adequately controlled
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  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
  • Known HIV or Hepatitis B or C (active, previously treated or both)
  • A history of other malignancy (except nonmelanoma skin cancer or carcinoma-in-situ of cervix), unless in CR and not receiving therapy for that disease for a minimum of 5 years
  • Patients with known hypersensitivity to any of the components of the drugs to be administered on study
  • Patients receiving concurrent investigational therapy (investigational therapy is defined as treatment for which there is currently no regulatory authority-approved indication)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University

    Baltimore, Maryland, 21231-1000

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

Other trials in United States

Spain1 site

  • Hospital Madrid

    Madrid, 28250

Other trials in Spain

About this study

Official title: A Phase 2, Open Label, Single Arm Trial of TPI 287 in Patients With Advanced, Unresectable Pancreatic Cancer After Prior Treatment With a Gemcitabine-based Therapy

The primary objective of the study is to assess the activity of TPI 287 as single agent therapy for patients with advanced, unresectable pancreatic cancer after failure of gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month survival rate.

Read the detailed description

This is a multicenter, open-label, single arm Phase 2 study in patients with advanced, unresectable pancreatic cancer who have received prior gemcitabine-based chemotherapy for their disease. Patients will receive TPI 287 administered as a 60-minute (± 10 min) IV infusion.

The primary endpoint of the trial will be the 6-month survival rate. Additional efficacy endpoints will be response rate, duration of response and stable disease, and 6-month progression free survival. Responses will be assessed by reduction in radiographically measurable disease as defined by the RECIST criteria. Time to worsening of clinical status will be based on reductions in pain and/or analgesic use and changes in tumor markers (CA 19-9) will also be followed.

Patients will remain on study until tumor progression or death, unacceptable toxicity, withdrawal of consent or discontinuation based on Investigator discretion. Patients will be followed for survival for up to 1 year after enrollment on the study.

Being tested
TPI 287
Keywords
Unresectable, Gemcitabine, Taxane, TPI 287
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPI 287Drug

    Intravenous dose of 125 mg/m2 TPI 287 on Day 1, Day 8, and Day 15 in a repeating 28 day cycle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Measured: 6 Months

Secondary outcomes (6)

  1. Overall Response Rate

    Measured: Ongoing

  2. Evaluate time to worsening of clinical status as measured by changes in pain, Karnofsky score, and weight.

    Measured: Ongoing

  3. Response rates and time to progression of tumor marker levels (CA 19-9)

    Measured: Ongoing

  4. Assess the safety and tolerability of TPI 287 in this patient population

    Measured: Ongoing

  5. Evaluate outcomes of patient subsets defined by duration of prior gemcitabine therapy

    Measured: Ongoing

  6. Evaluate the gene expression profile in relation to clinical outcomes

    Measured: Ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionSep 2009
  4. Study completionApr 2010

Why it stopped: Insufficient funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553813
Sponsor's protocol ID
TPI 287-06
Status last verified
Jan 2014
First submitted
2 Nov 2007
Last updated
22 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TPI 287 in people with Pancreatic Cancer, run by Cortice Biosciences, Inc. at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00553813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.

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